NP responded to a question about the mTNBC trials
Post# of 155566
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Posted On: 07/15/2020 11:59:16 PM
NP responded to a question about the mTNBC trials during the Wall Street Reporter interview last week. I believe the question was in regards to enrollment numbers and progress. NP said, if I’m recalling correctly, that CYDY is nearing full enrollment and completion of the phase 1B portion of the trial. The phase 1B portion consists of 18 patients, split into 3 groups of 6 each, for a 350mg arm, 525mg arm, and a 700mg arm. The phase 1B is meant to test for the maximum tolerated dose when combined with carboplatin.
The phase 2 part of the trial consists of 30 patients and tests the maximum tolerated dose of Leronlimab with carboplatin and looks at a myriad of endpoints, including survival, CTCs, CAMLs, new metastasis, etc.
I bring this up because cancer is the most exciting indication and nearing 18 patients for the phase 1B would be great news as that means there could be, in the near future, CTC and CR scan data from 18 patients over a number of months for the pre-BTD meeting. My hope is that Dr. Kelly’s oncology addition to the scientific board can assist in speeding up enrollment and expanding the number of sites recruiting.
https://clinicaltrials.gov/ct2/show/NCT038383...amp;rank=4
The phase 2 part of the trial consists of 30 patients and tests the maximum tolerated dose of Leronlimab with carboplatin and looks at a myriad of endpoints, including survival, CTCs, CAMLs, new metastasis, etc.
I bring this up because cancer is the most exciting indication and nearing 18 patients for the phase 1B would be great news as that means there could be, in the near future, CTC and CR scan data from 18 patients over a number of months for the pre-BTD meeting. My hope is that Dr. Kelly’s oncology addition to the scientific board can assist in speeding up enrollment and expanding the number of sites recruiting.
https://clinicaltrials.gov/ct2/show/NCT038383...amp;rank=4
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